Executive Summary
Outpatient surgery providers face new scrutiny from CMS and accreditation surveyors regarding the handling of multiple-dose vials.
- Dedicate a multi-dose vial to a single patient whenever possible.
- Some facilities, on a case-by-case basis, opt to make a judgment in the best interest of patients, while considering the drug entity, the emergent status of need, and whether alternative drugs exist, in collaboration with the medical director and/or the anesthesia provider.
When it comes to the sensitive issue of using one vial on one patient, do you feel as if you’re in a no-win position? If so, you’re not alone.
“On one hand is the need to adhere to DEA [Drug Enforcement Administration] and CMS guidelines, and on the other hand the cost and the waste costs associated with ‘one patient/one-vial’ standards, means that we are clearly wasting a valuable and limited-supply medication that could cause other patients to be denied care,” says Mark Mayo, CASC, executive director of Golf Surgical Center in Des Plaines, IL.
Ambulatory surgery centers have the additional challenge that short-supply medications go first to hospitals “where inpatient needs trump any elective outpatient need,” Mayo says. “Patient care can be compromised when less effective medications must be substituted.”
Cost is also an issue, he says. “Manufacturers must, out of supply-cost necessity, charge significantly more for true single dose vials, ampules, which will drive the cost per patient higher,” Mayo says.
He acknowledges the other side of the issue. “… [T]here is always some increased risk of incorrect draw procedures, mislabeling, and even contamination or dilution caused by illegal diversion of some open medications — a drug-dependent person could easily draw out from a bottle and replace it with water or another possibly contaminated liquid — and possible failure to adhere to strict standards,” says Mayo, referring to standards such as those to check the vial, disinfect the stopper, label drawn syringes, and always verify both the manufacturer’s expiration date and the 28-day expiration date. There can be failure to have proper storage under control, such as medications being locked away, and failure to have enhanced quality surveillance in which managers look for any patterns of cross-contamination, illness, injury, or apparent lack of potency due to possible illegal drug diversion.
“Obviously, the ideal is for the provider to open sealed medication, draw, label if not immediately used, administer, and discard unused portion, so there is no possibility of error or distortion of the medication,” Mayo says. However, he and others acknowledge that providers “are wasting most of the drug order to achieve absolute safe control, which could still be subject to illegal diversion should a drawn syringe be switched out by a drug-abusing staffer.” Mayo also adds that manufacturer-labeled uses must be followed. If it says “For single patient use,” that is how it must be administered, he says, and unused portions must be wasted.
On top of all of these concerns, there is updated guidance from CMS and increased interest from surveyors.
Jan Allison, RN, CHSP, of Washington, OK, director of accreditation and survey readiness for Surgical Care Affiliates, says, “The proper use of multi-dose vials is one of the key infection control practices monitored by surveyors since misuse of medication vials was identified as a significant cause of outbreaks of infectious diseases in patients throughout the healthcare industry.”
Subsequently surveyors have increased their awareness of the additional steps needed to ensure multi-dose vials aren’t contaminated when used for more than one patient, Allison says. “As surveyors have more recently become better educated, they have been placing more focus on these additional steps,” she says.
In a letter from CMS to its state survey agency directors, the agency spells out changes to the Ambulatory Surgical Center Infection Control Surveyor Worksheet and its Manual Instructions. The changes to instructions to surveyors for injection practices includes an “unable to observe” selection, in addition to “yes” and “no.” The instructions say the following:
“If ‘unable to observe’ is selected, please clarify in the surveyor notes box why it was not observed and attempt to assess by means of interview or documentation review. NOTE: Some types of infection control breaches, including some specific to medication administration practices, pose a risk of bloodborne pathogen transmission that warrant engagement of public health authorities. When management review confirms that a survey has identified evidence of one or more of the breaches described in Survey & Certification (S&C): 14-36-All, in addition to taking appropriate enforcement action to ensure the deficient Medicare practices are corrected, the State Agency should also make the responsible State public health authority aware of the identified breach.”
The instructions include the following (new wording is in italics):
- “B. Syringes are used for only one patient (this includes manufactured prefilled syringes).
- “C. The rubber septum on a medication, whether unopened or previously accessed, vial is disinfected with alcohol prior to piercing.
- “H. The ASC has voluntarily adopted a policy that medications labeled for multi-dose use for multiple patients are nevertheless only used for one patient. (Note: a “No” answer to question H. does not indicate a breach in infection control practices and does not result in a citation. However, a “No” response to either or both of the related questions I and J should be cited).
- “J. Multi-dose medication vials used for more than one patient are stored appropriately and do not enter the immediate patient care area (e.g., operating room, anesthesia carts).” (To access all of the changes, go to http://go.cms.gov/1D9wRcO.)
“In an ambulatory surgery center, the immediate patient treatment area is defined in the preoperative and postoperative units as the patient bedside, but in the operating room or procedure room, this involves the entire space,” Allison says. The reason for this practice is to prevent someone inadvertently contaminating the vial through contact, direct or indirect, with surfaces or equipment that could be contaminated, she says. “So this can make it particularly challenging during a procedure when the anesthesia provider accesses a multi-dose vial for a patient in the operating or procedure room and can no longer use that vial for multiple patients,” Allison says. “The medication vial must be dedicated to that patient only.” Have a significant amount of medication left in the vial? It ends up being wasted, she says.
Sheldon Sones, RPh, FASCP, a pharmacy consultant based in Newington, CT, points to a changing dynamic over recent years. “… [T]he standards are very clear that multiple-dose vials used in patient care areas are to be used for single patients only,” Sones says. He says that vials not used in direct patient areas should be dated, and the expiration date should be at 28 days. “Of course, the chronic problem with drug shortages has exacerbated the efforts to remain compliant with the standard and at the same time meet the immediate needs of patients, Sones says. (See story in this issue on how to handle drug shortages.)
In the facilities with which Sones consults with, he emphasizes the established standard because of the problems linked to mishandling of multiple-dose vials. “However, there is that delicate balance that we must be sensitive to,” he says. The trend is toward a single-dose model for medications within sterile environments and in proximity to patients.
“Certainly, if I was an anesthesia provider, I would be reluctant to use a multiple-dose vial handled by another provider on a previous case or day,” Sones says. “I would be taking responsibility for the integrity of the product and could not comfortably do so if the product was not under my direct control from the time of opening.”
When it comes to the sensitive issue of using one vial on one patient, do you feel as if you’re in a no-win position? If so, you’re not alone.
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